NVP 25 mg+50 mg Tablet

NVP 25 mg+50 mg Tablet

DESCRIPTION

NVP is a combination of Meclizine HCl and Pyridoxine HCl.

Meclizine HCl is a piperazine-derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It exhibits its action by an effect on CNS, possibly by its ability to block muscarinic receptors in the brain. It has marked effects in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. It reduces the sensitivity of the labyrinthine apparatus. The site and mechanism of action of Meclizine HCl in controlling vertigo from various conditions have not been clearly defined. Pyridoxine HCl

(Vit. B6) either alone or combination has been used to prevent nausea and vomiting due to its antiemetic properties.

COMPOSITION

NVP tablet : Each film-coated tablet contains Meclizine HCl USP 25 mg and Pyridoxine HCl USP 50 mg.

INDICATIONS

For prophylaxis and symptomatic relief of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of vestibular system (e.g. menier’s syndrome, labyrinthitis and other vestibular disturbances) and morning sickness during pregnancy.

DOSAGE AND ADMINISTRATION

NVP is recommended for oral administration. Nausea & vomiting (including morning sickness in pregnancy):

One tablet 1-2 times daily.

Motion sickness: The initial dose is one or two tablets daily, it should be taken one hour prior to journey for protection against motion sickness. The dose may be repeated every 24 hours as indicated for the duration of journey.

Vertigo : 1-4 tablets daily in divided dosage.

Labyrinthine and vestibular disturbances : The optimal dosage of

Meclizine HCl is usually 25 to 100 mg daily in divided doses, depending on the clinical response.

Radiation sickness : 50 mg (Meclizine) administered 2 to 12 hours prior to radiation treatment.

Or AS DIRECTED BY THE PHYSICIAN

SIDE EFFECTS

Drowsiness, dry mouth, urinary retention on rare occasions and blurred vision have been reported.

USE IN CHILDREN

The safety and efficacy for use in children less than 12 years of age have not been established.

USE IN PREGNANCY AND LACTATION

Meclizine HCl : Pregnancy category B. Large scale human studies have not demonstrated adverse fetal effects. It has been suggested that, based on available data, meclizine presents the

lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy.

Pyridoxine HCl : Pyridoxine HCl itself is considered safe during pregnancy.

Safety for use in nursing mothers has not been established.

PRECAUTIONS

Due to its potential anticholinergic action, patients with asthma, bronchitis, emphysema, enlarged prostate, glaucoma or urinary tract blockade should take Meclizine with caution. Patients should avoid alcoholic beverages while taking this drug.

CONTRAINDICATION

Meclizine HCl and Pyridoxine HCl are contraindicated in individuals who have shown a previous hypersensitivity to any of these ingredients.

DRUG INTERACTIONS

There may be increased CNS depression when Meclizine HCl and

Pyridoxine HCl is administered concurrently with other CNS depressants, including benzodiazepines, barbiturates, tricyclic antidepressants, opiate agonists, skeletal muscle relaxants, antihistamines, alcohol, tranquilizers. Meclizine HCl can increase the absorption of dioxin by decreasing gastrointestinal motility.

MAO inhibitors may prolong and intensify the anticholinergic effects of Meclizine HCl.

SUPPLY

Each box contains 5 x 10 tablets in blister strips.